Biotechnology & Nanotechnology Regulation
Select a format
Biotechnology & Nanotechnology Regulation (2017 Edition), by David Naidu, analyzes regulation governing biotechnology and nanotechnology industries. Regulation of biotechnology, which generally encompasses the manipulation of living materials by passing genetic information from one organism to another, emerged in the 1970's and is of major concern to the medical, pharmaceutical, chemical manufacturing, and agricultural fields. Nanotechnology, which refers to the design and production of molecular-sized devices and products, is a more recent field whose regulation has an impact on the same industries as biotechnology and also affects semiconductors, communications technology, cosmetics, and consumer products. Both fields are subject to the same regulatory schemes, and this book describes the application of substantive laws, such as the Federal Food, Drug, and Cosmetic Act, the Clean Water Act, and the Clean Air Act, to each segment of the biotechnology nanotechnology industry. Also discussed are international issues and ongoing development of regulations governing these fields. The 2015 Edition includes coverage of (1) new state efforts to regulate the labeling of genetically modified foods and the legal challenges to such attempts; (2) the Ninth Circuit decision on nanosilver and the implications for regulation of products that contain nanoscale antimicrobial products; and (3) new FDA guidance documents that outline how they would evaluate whether a product should be considered as made from nanotechnology.
• Examines controversies generated by biotechnology in both the United States and Europe and explains how these controversies will affect the ongoing development of regulation
• Regulation of biotechnology and nanotechnology is of major concern to the medical, pharmaceutical, chemical manufacturing, and agricultural fields
• The fields of biotechnology and nanotechnology have grown rapidly and are expected to require increased levels of legal services
"David Naidu's work is thoughtful and comprehensive."
Executive Chairman, NanoBusiness Alliance
"A valuable resource for practitioners, academics, and policy-makers who seek a comprehensive yet concise overview of the two key areas at the intersection of law and science."
--Linda K. Breggin
Senior Attorney and Director, Nanotechnology Initiative, Environmental Law Institute
Table of Contents
CHAPTER 1 INTRODUCTION TO REGULATION OF BIOTECHNOLOGY AND NANOTECHNOLOGY
CHAPTER 2 WHAT IS BIOTECHNOLOGY? WHAT IS NANOTECHNOLOGY?
CHAPTER 3 UNDERSTANDING THE RISKS FROM NANOTECHNOLOGY AND BIOTECHNOLOGY
CHAPTER 4 CREATION OF A REGULATORY STRUCTURE
CHAPTER 5 REGULATION OF TRANSGENIC PLANTS AND ANIMALS
CHAPTER 6 REGULATION OF FOOD
CHAPTER 7 DRUGS, BIOLOGICS, AND MEDICAL DEVICES
CHAPTER 8 COSMETICS
CHAPTER 9 CONSUMER PRODUCTS
CHAPTER 10 CHEMICALS
CHAPTER 11 EVOLUTION OF BIOTECHNOLOGY REGULATION AND THE FUTURE OF NANOTECHNOLOGY REGULATION